Phase 2
N=204
Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery
Adenocarcinoma of the Prostate · Stage II Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00438464 ↗Enrolled (actual)
204
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy — 80; 90; 15.0; 6.6 Percentage tumor cell involvement — p=0.70
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Finasteride (Drug); Placebo (Other); Prostatectomy (Procedure); Laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy |
63.9; 63.7; 18.1; 14.8; 69.8; 72.4 | — |
| PRIMARY Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy |
63.6; 59.8; 15.0; 16.7; 64.3; 68.6 | — |
| PRIMARY Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy |
63.9; 63.7; 18.1; 14.8; 69.8; 72.4 | — |
| PRIMARY Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy |
63.6; 59.8; 15.0; 16.7; 64.3; 68.6 | — |
| SECONDARY Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score |
12; 10; 71; 78; 2; 1 | — |
| SECONDARY Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary) |
65; 75; 23; 18 | — |
| SECONDARY Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary) |
31; 24; 53; 64; 4; 5 | — |
| SECONDARY Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage |
73; 74; 11; 15; 5; 5 | — |
| SECONDARY Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR) |
17; 16; 67; 76; 5; 2 | — |
| SECONDARY Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status |
46; 43; 2; 2; 41; 49 | — |
| SECONDARY Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci |
15; 11; 18; 20; 28; 28 | — |
| SECONDARY Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS) |
35; 38; 49; 50; 2; 2 | — |
| SECONDARY Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus |
67; 73; 22; 21 | — |
| SECONDARY Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy |
63; 70; 26; 24 | — |
| SECONDARY Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter) |
1.0; 0.8; 0.6; 0.5; 0.0; 0.0 | — |
| SECONDARY Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%) |
-39.4; -4.6 | <0.001 sig |
| SECONDARY Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change |
13; -4.6 | 0.003 sig |
| SECONDARY Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change |
-64.8; -3.6 | <0.001 sig |
| SECONDARY Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change |
-8.9; 0 | 0.805 |
| SECONDARY Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change |
7.2; 0 | 0.254 |
| SECONDARY Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) |
63.9; 63.7; 18.1; 15.0; 69.8; 64.3 | — |
| SECONDARY Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) |
63.7; 59.7; 14.8; 16.7; 72.4; 68.6 | — |
| SECONDARY Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups |
80; 85; 15.0; 8.0; 75.2; 63.7 | 0.84 |
| SECONDARY Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups |
90; 70; 6.6; 9.5; 78.3; 75.9 | 0.32 |
Summary
This randomized phase II trial studies how well finasteride works in treating patients with stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Giving finasteride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Eligibility Criteria
Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- Clinical stage T1c or T2 (stage II)
- Gleason score of 6 or 7 on initial biopsy
- Prostate-specific antigen (PSA) level less than 10 ng/mL within the past 3 months
- Candidate for and scheduled to undergo prostatectomy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 70-100%
- Fertile patients must use effective contraception
- No active malignancy at any other site
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to finasteride
- No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia
- No psychiatric illness or social situation that would preclude study compliance
- More than 6 months since prior hormonal agents, including dutasteride or finasteride
- More than 6 months since prior chemotherapy
- More than 1 month since prior participation in another investigational study
- No prior radiotherapy for the primary tumor
- No concurrent dehydroepiandrosterone, phytoestrogen supplements, antiandrogen therapy, dutasteride, or other finasteride
- No concurrent anticoagulation, except for the use of daily acetylsalicylic acid (81 mg to 325 mg)
Data sourced from ClinicalTrials.gov (NCT00438464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.